Study to the presence of antipolymer antibodies in a group of Dutch women with a silicone breast implant. Part II

The presence of antipolymer antibodies (APA) was reported in women with severe symptoms and a silicone breast implant (SBI). The aim of the present study was to determine whether there exists a population of symptomatic SBI recipients with a high prevalence of APA in the Netherlands. Participants were selected using a questionnaire which included a screening for connective tissue diseases, the Shortened Fatigue Questionnaire, and the RAND 36 item Health Survey. In addition, information was obtained from the general practitioner on the disease status of the women. A total of 42 SBI recipients were included in the study age ranging from 31 - 73 years. The mean SBI exposure was 16 years. The participants were clinically examined and serum samples were obtained. Serum samples of eighty women age 26 - 69 years (study group plus or minus five years) were evaluated as controls. The study population of SBI recipients was categorized in severity subgroups based on the functional capacity, and the study physician's general assessment of pain and disease activity. Most (31 of 42) SBI recipients belonged to the limited severity subgroup on an increasing scale of limited, mild, moderate and advanced. Five of the 42 SBI recipients (11.9%, 95% confidence interval 4.0%-25.6%) showed a positive response for APA in their serum. All APA positive participants were classified in the limited severity subgroup. In the control group five of the 80 women (6.3%, 95% confidence interval 2.1%-14.0%) showed an APA positive reaction. The small difference between the SBI recipients and the control group is not statistically significant. In conclusion, although we cannot confirm nor negate the reported results on the presence of antipolymer antibodies (APA) in symptomatic SBI recipients, our failure in two studies to recruit symptomatic SBI recipients suggests that the population of severely symptomatic SBI recipients in the Netherlands is rather small. In addition, also in the normal population a substantial number of positive reacting women were observed. Hence, we cannot recommend the use of the APA assay for diagnostic purposes in the clinical evaluation of SBI recipients with severe complaints/symptoms